Pelvic Organ ProlapseM2R2NCT05918367
Multicenter Ventral Mesh Rectopexy Registry Collaborative
An observational study of Pelvic Organ Prolapse and Rectocele, run by University Hospital, Antwerp at 5 sites in Belgium.
Trial summary
The goal of this multicenter observational study is to collect data prospectively of patients with pelvic organ prolapse undergoing ventral mesh rectopexy (as well as rectoceles, entero-/sigmoidoceles/ intussusception/ rectal prolapse or combined) by laparoscopy or robotic surgery and to evaluate the longterm… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic Organ Prolapse, Rectocele, Enterocele
- How many people
- 200 participants
- Where
- 5 sitesBelgium
- Study dates
- 25 Sep 2023to 30 Sep 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pelvic organ prolapse undergoing ventral mesh rectopexy (as well as rectoceles, entero-/sigmoidoceles/ intussusception/ rectal prolapse or combined)
Who may be able to join
- Diagnosis of posterior pelvic organ prolaps planned for laparoscopie or robotic ventral mesh rectopexy with or without concomittant surgery.
- All patients 18 years or older and are able to complete a written informed conscent are eligble for inclusion.
Who cannot join
- Inability to complete a written informed conscent
- Pregnant women
- No email adress available to send the questionnaires to
- Language barrier or impossiblity to fill in the questionnaires (at the discretion oft he treating physician)
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Belgium5 sites, 5 recruiting
- Recruiting
UZ Brussel
Brussels
Jasper Stijns, jasper.stijns@uzbrussel.be
- Recruiting
University Hospital Antwerp
Edegem, 2650
Sylvie Van den Broeck, 00328215744, sylvie.vandenbroeck@uza.be
- Not yet recruiting
AZ Jan Palfijn
Ghent
Emmelie Reynvoet, emmelie.reynvoet@janpalfijngent.be
- Recruiting
Jessa ziekenhuis
Hasselt
Bert Houben, bert.houben@jessazh.be
- Recruiting
AZ Delta Roeselare
Roeselare
Paul Pattyn, paul.pattyn@azdelta.be
About this study
The goal of this multicenter observational study is to collect data prospectively of patients with pelvic organ prolapse undergoing ventral mesh rectopexy (as well as rectoceles, entero-/sigmoidoceles/ intussusception/ rectal prolapse or combined) by laparoscopy or robotic surgery and to evaluate the longterm functional outcomes.
Secondly complications (mesh erosions, recurrence, reoperations) are evaluated.
Read more
Following main questions will be analysed - other can follow in consultation with the collaborative
- Is VMR the technique of choice for treatment of rectoceles? Functional results - recurrence - mesh related complications
- Has a perineal descent an impact on the functional outcome of ventral mesh rectopexy perfored for external rectal prolaps, internal rectal prolaps, rectocele, enterocele, sigmoidcele or combined pelvic organ prolapse?
Read the detailed description
The study M2R2 is a multicentre registry based on the still ungoing monocentre study in the University Hospital of Antwerp.
Pelvic organ prolapse (POP) is a benign condition in which pelvic organs prolapse beyond their normal anatomical position due to weakening or damage to the pelvic floor muscles and other supporting tissues.[1] The incidence increases with age, multiparity, vaginal delivery and obesity.[2] POP can cause urinary, sexual and bowel complaints with a huge impact on quality of life.[3,4] Patients with posterior compartment prolapse may include symptoms of vaginal swelling, heaviness, perineal pressure and/or obstructive defecation with fragmented stools, need for hard straining, feeling of incomplete emptying, splinting, faecal urgency and even incontinence.[4] Ventral mesh rectopexy is surgical technique used to treat posterior compartment prolapse (rectocele, enterocele, sigmoidocele, rectal prolapse, combination) in patients with symptoms where conservative therapy fails or is ineffective. In this procedure, a mesh is placed between the back wall of the vagina and the rectum, the rectovaginal septum. This is attached at the level of the bone higher up (the promontorium) so that the back wall of the vagina is reinforced, preventing the prolapse to recurre.This technique was first described as technique to treat rectal prolapse by d'Hoore, a colorectal surgeon and widely accepted given the feasible transabdominal technique with good functional results. However, whether this technique gives also effective long-term anatomical and functional outcomes for rectoceles, enteroceles/sigmoidoceles +/- perineal descent, besides rectal prolapse, is not known.[5,6] Sometimes a combined procedure is necessary in which the anterior compartment (bladder) and/or middle compartment (cervix/vagina tip) is also reinforced.
The main objective of this registry is to collect data prospectively of patients with pelvic organ prolapse undergoing ventral mesh rectopexy (as well as rectoceles, entero-/sigmoidoceles/ intussusception/ rectal prolapse or combined) by laparoscopy or robotic surgery and to evaluate the longterm functional outcomes.
Secondly complications (mesh erosions, recurrence, reoperations) are evaluated.
The patients will be recruited from outpatient clinic of abdominal surgery in the participating centers. The treating physician recruits patients.
Methods and analysis
- Data registry Parameters will be registered by means of case record form: History of the patient, urinary, prolapse, defecatory complaints, MRI or CR CCD if performed, anal manometry if performed, results of pelvic floor physiotherapy if performed. Surgical technique, operation time/length of stay and complications.
- Questionnaire send to the patients at 5 time points Preoperative - 3 months - 1 year - 3 years - 5 years postoperative Questionnaires consisting of different topics I. In female: questions about childbirth (only preoperative) II. Medication III. Inventarisation of pelvic floor (dys)- function: PFDI-20 IV. Intestinal function and constipation
- Wexner Vaizey-score
- Low anterior resection syndrome score (LARS)
- Bristol stool chart
- Rome IV criteria functionam obstipation
- Rome IV criteria IBS
- CCS (Wexner constipation score)
- Urinary (ICIQ-SF) VI. Seksuality (PISC-IR) VII. Impact of pelvic floor problem on quality of life (PISQ-7) VIII. Subjective satisfaction after surgery
- Data management
Collected data will be entered in a case record form by the treating physician of the participating centre or by assigned study staff using the RedCap platform. Patients will be coded to insure patient anonymity.
- Conditions
- Pelvic Organ Prolapse, Rectocele, Enterocele, Rectal Prolapse, Descending Perineum Syndrome, Surgery
- Keywords
- Posterior pelvic organ prolapse, descending perineum, ventral mesh rectopexy, functional outcome
- Medical subject headings
- Pelvic Organ Prolapse, Rectocele, Hernia, Rectal Prolapse
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome
Evaluation of the long-term functional outcomes of ventral mesh rectopexy (VMR) for posterior organ prolapse. Is VMR the surgical technique of choice for treatment of rectoceles?
Measured: 5 years
Has perineal descent has an impact on the functional outcome of ventral mesh rectopexy performed for external rectal prolaps, internal rectal prolaps, rectocele, enterocele, sigmoidocele or combined pelvic organ prolapse?
Measured: 5 years
Secondary outcomes (2)
recurrence of posterior pelvic organ prolapse - new onset of symptoms
Measured: 5 years
mesh related complications
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start25 Sep 2023
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918367
- Sponsor's protocol ID
- 001130
- Acronym
- M2R2
- Status last verified
- Jun 2023
- First submitted
- 15 Jun 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Weintraub AY, Glinter H, Marcus-Braun N. Narrative review of the epidemiology, diagnosis and pathophysiology of pelvic organ prolapse. Int Braz J Urol. 2020 Jan-Feb;46(1):5-14. doi: 10.1590/S1677-5538.IBJU.2018.0581.
PubMed 31851453Vergeldt TF, Weemhoff M, IntHout J, Kluivers KB. Risk factors for pelvic organ prolapse and its recurrence: a systematic review. Int Urogynecol J. 2015 Nov;26(11):1559-73. doi: 10.1007/s00192-015-2695-8. Epub 2015 May 13.
PubMed 25966804Pelvic Organ Prolapse: ACOG Practice Bulletin, Number 214. Obstet Gynecol. 2019 Nov;134(5):e126-e142. doi: 10.1097/AOG.0000000000003519.
PubMed 31651832Doumouchtsis SK, Raheem AA, Milhem Haddad J, Betschart C, Contreras Ortiz O, Nygaard CC, Medina CA, La Torre F, Iancu G, Cervigni M, Zanni G. An update of a former FIGO Working Group Report on Management of Posterior Compartment Prolapse. Int J Gynaecol Obstet. 2020 Feb;148(2):135-144. doi: 10.1002/ijgo.13006. Epub 2019 Nov 19.
PubMed 31628853D'Hoore A, Penninckx F. Laparoscopic ventral recto(colpo)pexy for rectal prolapse: surgical technique and outcome for 109 patients. Surg Endosc. 2006 Dec;20(12):1919-23. doi: 10.1007/s00464-005-0485-y.
PubMed 17031741D'Hoore A, Cadoni R, Penninckx F. Long-term outcome of laparoscopic ventral rectopexy for total rectal prolapse. Br J Surg. 2004 Nov;91(11):1500-5. doi: 10.1002/bjs.4779.
PubMed 15499644
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Ventral Mesh Rectopexy Registry Collaborative
- ClinicalTrials.gov ID
- NCT05918367
- Acronym / sponsor ID
- M2R2 / 001130
- Conditions
- Pelvic Organ Prolapse, Rectocele, Enterocele, Rectal Prolapse, Descending Perineum Syndrome, Surgery
- Keywords
- Posterior pelvic organ prolapse, descending perineum, ventral mesh rectopexy, functional outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2032 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this multicenter observational study is to collect data prospectively of patients with pelvic organ prolapse undergoing ventral mesh rectopexy (as well as rectoceles, entero-/sigmoidoceles/ intussusception/ rectal prolapse or combined) by laparoscopy or robotic surgery and to evaluate the longterm functional outcomes.
Secondly complications (mesh erosions, recurrence, reoperations) are evaluated.
Following main questions will be analysed - other can follow in consultation with the collaborative
- Is VMR the technique of choice for treatment of rectoceles? Functional results - recurrence - mesh related complications
- Has a perineal descent an impact on the functional outcome of ventral mesh rectopexy perfored for external rectal prolaps, internal rectal prolaps, rectocele, enterocele, sigmoidcele or combined pelvic organ prolapse?
Detailed description
The study M2R2 is a multicentre registry based on the still ungoing monocentre study in the University Hospital of Antwerp.
Pelvic organ prolapse (POP) is a benign condition in which pelvic organs prolapse beyond their normal anatomical position due to weakening or damage to the pelvic floor muscles and other supporting tissues.[1] The incidence increases with age, multiparity, vaginal delivery and obesity.[2] POP can cause urinary, sexual and bowel complaints with a huge impact on quality of life.[3,4] Patients with posterior compartment prolapse may include symptoms of vaginal swelling, heaviness, perineal pressure and/or obstructive defecation with fragmented stools, need for hard straining, feeling of incomplete emptying, splinting, faecal urgency and even incontinence.[4] Ventral mesh rectopexy is surgical technique used to treat posterior compartment prolapse (rectocele, enterocele, sigmoidocele, rectal prolapse, combination) in patients with symptoms where conservative therapy fails or is ineffective. In this procedure, a mesh is placed between the back wall of the vagina and the rectum, the rectovaginal septum. This is attached at the level of the bone higher up (the promontorium) so that the back wall of the vagina is reinforced, preventing the prolapse to recurre.This technique was first described as technique to treat rectal prolapse by d'Hoore, a colorectal surgeon and widely accepted given the feasible transabdominal technique with good functional results. However, whether this technique gives also effective long-term anatomical and functional outcomes for rectoceles, enteroceles/sigmoidoceles +/- perineal descent, besides rectal prolapse, is not known.[5,6] Sometimes a combined procedure is necessary in which the anterior compartment (bladder) and/or middle compartment (cervix/vagina tip) is also reinforced.
The main objective of this registry is to collect data prospectively of patients with pelvic organ prolapse undergoing ventral mesh rectopexy (as well as rectoceles, entero-/sigmoidoceles/ intussusception/ rectal prolapse or combined) by laparoscopy or robotic surgery and to evaluate the longterm functional outcomes.
Secondly complications (mesh erosions, recurrence, reoperations) are evaluated.
The patients will be recruited from outpatient clinic of abdominal surgery in the participating centers. The treating physician recruits patients.
Methods and analysis
- Data registry Parameters will be registered by means of case record form: History of the patient, urinary, prolapse, defecatory complaints, MRI or CR CCD if performed, anal manometry if performed, results of pelvic floor physiotherapy if performed. Surgical technique, operation time/length of stay and complications.
- Questionnaire send to the patients at 5 time points Preoperative - 3 months - 1 year - 3 years - 5 years postoperative Questionnaires consisting of different topics I. In female: questions about childbirth (only preoperative) II. Medication III. Inventarisation of pelvic floor (dys)- function: PFDI-20 IV. Intestinal function and constipation
- Wexner Vaizey-score
- Low anterior resection syndrome score (LARS)
- Bristol stool chart
- Rome IV criteria functionam obstipation
- Rome IV criteria IBS
- CCS (Wexner constipation score)
- Urinary (ICIQ-SF) VI. Seksuality (PISC-IR) VII. Impact of pelvic floor problem on quality of life (PISQ-7) VIII. Subjective satisfaction after surgery
- Data management
Collected data will be entered in a case record form by the treating physician of the participating centre or by assigned study staff using the RedCap platform. Patients will be coded to insure patient anonymity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pelvic organ prolapse undergoing ventral mesh rectopexy (as well as rectoceles, entero-/sigmoidoceles/ intussusception/ rectal prolapse or combined)
Key inclusion criteria (2 listed)
- Diagnosis of posterior pelvic organ prolaps planned for laparoscopie or robotic ventral mesh rectopexy with or without concomittant surgery.
- All patients 18 years or older and are able to complete a written informed conscent are eligble for inclusion.
Key exclusion criteria (4 listed)
- Inability to complete a written informed conscent
- Pregnant women
- No email adress available to send the questionnaires to
- Language barrier or impossiblity to fill in the questionnaires (at the discretion oft he treating physician)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional outcome
Time frame: 5 years
Evaluation of the long-term functional outcomes of ventral mesh rectopexy (VMR) for posterior organ prolapse. Is VMR the surgical technique of choice for treatment of rectoceles?
Has perineal descent has an impact on the functional outcome of ventral mesh rectopexy performed for external rectal prolaps, internal rectal prolaps, rectocele, enterocele, sigmoidocele or combined pelvic organ prolapse?
Time frame: 5 years
2 secondary outcomes
recurrence of posterior pelvic organ prolapse - new onset of symptoms
Time frame: 5 years
mesh related complications
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Results publication: PubMed 31851453Weintraub AY, Glinter H, Marcus-Braun N. Narrative review of the epidemiology, diagnosis and pathophysiology of pelvic organ prolapse. Int Braz J Urol. 2020 Jan-Feb;46(1):5-14. doi: 10.1590/S1677-5538.IBJU.2018.0581.
- Results publication: PubMed 25966804Vergeldt TF, Weemhoff M, IntHout J, Kluivers KB. Risk factors for pelvic organ prolapse and its recurrence: a systematic review. Int Urogynecol J. 2015 Nov;26(11):1559-73. doi: 10.1007/s00192-015-2695-8. Epub 2015 May 13.
- Results publication: PubMed 31651832Pelvic Organ Prolapse: ACOG Practice Bulletin, Number 214. Obstet Gynecol. 2019 Nov;134(5):e126-e142. doi: 10.1097/AOG.0000000000003519.
- Results publication: PubMed 31628853Doumouchtsis SK, Raheem AA, Milhem Haddad J, Betschart C, Contreras Ortiz O, Nygaard CC, Medina CA, La Torre F, Iancu G, Cervigni M, Zanni G. An update of a former FIGO Working Group Report on Management of Posterior Compartment Prolapse. Int J Gynaecol Obstet. 2020 Feb;148(2):135-144. doi: 10.1002/ijgo.13006. Epub 2019 Nov 19.
- Results publication: PubMed 17031741D'Hoore A, Penninckx F. Laparoscopic ventral recto(colpo)pexy for rectal prolapse: surgical technique and outcome for 109 patients. Surg Endosc. 2006 Dec;20(12):1919-23. doi: 10.1007/s00464-005-0485-y.
- Results publication: PubMed 15499644D'Hoore A, Cadoni R, Penninckx F. Long-term outcome of laparoscopic ventral rectopexy for total rectal prolapse. Br J Surg. 2004 Nov;91(11):1500-5. doi: 10.1002/bjs.4779.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse and Rectocele, run by University Hospital, Antwerp at 5 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvie Van den Broeck (003238215744, sylvie.vandenbroeck@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05918367, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.